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Mabama Doctors’ Hospital No. Adm.

2018-11-001
Page: 1 of 6
Title:
PHARMACY RISK Effective Date ( After approval by FDA)
MANAGEMENT PLAN Retires Policy Dated: None
Previous Versions Date None
Approval Date:

Pharmacy Risk Management Plan

INTRIDUCTION

Risk is defined as an event that has a probability of occurring, and could have either a
positive or negative impact to the lifecycle of a medicinal product. A risk may have one
or more causes and, if it occurs, one or more impacts either in cost, schedule or
performance, for example.

Risk management means managing a wide spectrum of risks that could affect the
practice of pharmacy. It involves protection of the patient, protection of the pharmacists
and technicians, and protection of the pharmacy itself. It goes beyond merely putting
the right tablets in the bottle with the correct directions on the label. It is even broader
than protecting the patient from harm, although that must remain the primary focus of
all.

SCOPE

This Plan applies to MDH Pharmacy, and ALL Drug products available.

OBJECTIVE

This guidance is intended to propose to FDA a standard concept for MDH Pharmacy
Risk Management Plan ( RMP) in order to deal with “Important identified risks” both
Pharmacovigilance and Risk Minimization Plan. The whole plan is called “Risk
Management Plan (RMP).” - This guidance should be used as a guideline when the
MDH Pharmacy considers further surveillances and studies regarding the safety of the
drug products available at the Pharmacy and additional actions to mitigate risks at
anytime when the need is identified. This guidance is intended to aid and improve
safety measures based on the MDH Pharmacy protocols.
Mabama Doctors’ Hospital No. Adm. 2018-11-001
Page: 2 of 6
Title:
PHARMACY RISK Effective Date ( After approval by FDA)
MANAGEMENT PLAN Retires Policy Dated: None
Previous Versions Date None
Approval Date:

Definition of Terms:

Risk - a set of pharmacovigilance activities and interventions designed to identify,


characterize, prevent or minimize risks relating to medicinal products including the
assessment of the effectiveness of those activities and interventions.

Risk Identification / Assessment - is a term used to describe the overall process or


method where you:

 Identify hazards and risk factors that have the potential to cause harm (hazard
identification).
 Analyze and evaluate the risk associated with that hazard (risk analysis, and
risk evaluation).
 Determine appropriate ways to eliminate the hazard, or control the risk when
the hazard cannot be eliminated (risk control).

Risk Minimization - is the process of doing everything possible to reduce the


probability and/or impact of a risk towards zero.

Risk Communication – Exchange of information and opinions, and establishments of


an effective dialogue, among those responsible for assessing, minimizing, and
regulating risks, and those who maybe affected by the outcome of those risk.

SAFETY SPECIFICATION

The Mabama Doctors’ Hospital Pharmacy, is a licensed hospital Pharmacy located


at Bonifacio Road, Pobalcion 2, Bansalan, Davao del Sur, owned by Mr. William
Lowell C. Bragat, and as owner, my responsibilities are below;

1. As a licensed hospital Pharmacy, our general risk management objective is to


ensure the safety, efficacy, and quality of drug products, and ensure compliance
with regulatory requirements Specifically,

– Ensure compliance to regulatory action

– Ensure compliance to GSP

– Ensure compliance to ethical business practices

2. To ensure that the data lock point is observed,


3. Ensure that all healthcare professionals such as Physicians, Nurses and
Pharmacists are medically qualified and competent,
Mabama Doctors’ Hospital No. Adm. 2018-11-001
Page: 3 of 6
Title:
PHARMACY RISK Effective Date ( After approval by FDA)
MANAGEMENT PLAN Retires Policy Dated: None
Previous Versions Date None
Approval Date:

4. That all Adverse Drug Reactions (ADR) and Adverse Event (AE) will be reported
to the Pharmacovigilance Center using the MDH Adverse Drug Reaction ( ADR)
Report Form,
5. To recall all Drug products that has an Adverse Drug Reactions from the
Pharmacy and general store room. Make report and return the product to the
distributor,
6. To update this MDH Pharmacy RMP when the need is identified and based on
the FDA guidelines and Circulars.

The MDH Risk Management Officer

To address the need of a Risk Management Plan in the MDH Pharmacy, the
Hospital Administrator appoint the Medical Director, Dr. Sylvia P. Bragat, FPPS as the
MDH Risk Management Officer. Under her, are the Chief Nurse and the Chief
Pharmacist. The term of reference of the MDH Risk Management Officer as follows;

1. Review and approve the risk policies and any material changes made to these;
2. To review and recommend to the Leadership and Management Committee
standards for the RMP which require their approval; and
3. Monitor compliance with the GSP ( cold-chain protocol ) and other policy in
MDH Pharmacy RMP

Risk Identification

1. Compliance to Regulatory Action

Objectives:
To be fully compliant with the FDA regulations and to have a complete list of
advisories and documentation of recall products.
Mabama Doctors’ Hospital No. Adm. 2018-11-001
Page: 4 of 6
Title:
PHARMACY RISK Effective Date ( After approval by FDA)
MANAGEMENT PLAN Retires Policy Dated: None
Previous Versions Date None
Approval Date:

Mitigation Plan Process:

Risk Description Level of Action to be Time / Responsible


Severity Taken Schedule Person
1. Compliance to
regulatory Action

1.1. Lack of Time Medium 1. Update at Every Pharmacist on


to Check at the FDA website Morning duty
FDA website Monday – Friday
1.2. Poor Internet Low 1. Contact the
Connection IT Pharmacist on
Every time
maintenance problem exist duty
Technician

1.3. Other Risk Low 1. To update


unidentified the MRP and Upon Risk
but may occur make report Identification Management
to FDA ( data Officer
lack point)

2. Compliance to Good Storage Practice ( GSP)

Objectives:
To be compliant with the protocol on Cold Chain, “that all products are stored and
maintained in correct temperature and to have a consistent temperature on the
monitoring charts.”

Mitigation Plan Process:


Risk Description Level of Action to be Time Responsible
Severity Taken /Schedule Person
2. Compliance to
Good Storage Practice
2.1. Cold Chain
Irregular Medium 1.To Check the Every Pharmacist on
Checking Refrigerator if Morning Duty
power is on Mondays to
2.To Check the
temperature of
Sundays
refrigerator and
record to chart
Mabama Doctors’ Hospital No. Adm. 2018-11-001
Page: 5 of 6
Title:
PHARMACY RISK Effective Date ( After approval by FDA)
MANAGEMENT PLAN Retires Policy Dated: None
Previous Versions Date None
Approval Date:

2.2. Power Outage Low 1. Start up the Within 20 Maintenance


Generator Set minutes from Technician
the time of On duty
power
interruption

2.3. Malfunctioning Medium 1. To Replace Upon detection Pharmacist on


of
Monitoring Equipment the monitoring malfunctioning
Duty
equipment 1. Prepare
Purchase
Request

2.4. Malfunctioning 1. Request 1. Upon Pharmacist on


Refrigerator Low repair of the detection of Duty
Refrigerator malfunctioni
2. Transfer the ng
Note: Refer to drugs to
1.Contingency Plan for another
Both Mechanical and refrigerator
Power failure
2. Maintenance and
care of the Bio Ref.
3. Monitoring and
Adjusting of Temp. of
Bio Ref.

Risk Minimization:

Standards:

In order to minimize the Risks, the above step by step mitigation planned activities
shall be followed. The Risk Management Officer shall review and monitor
compliance to the above standards. If upon review, the Risk Management Officer
found that the above planned activities were routinely performed by the responsible
persons and still not sufficient to manage the risks, then a supplemental policy shall be
formulated to address the current and the newly identified risks.
Mabama Doctors’ Hospital No. Adm. 2018-11-001
Page: 6 of 6
Title:
PHARMACY RISK Effective Date ( After approval by FDA)
MANAGEMENT PLAN Retires Policy Dated: None
Previous Versions Date None
Approval Date:

Risk Monitoring and Management Evaluation

Standards:

1. The MDH Pharmacy RMP will be reviewed and revised at the end of the data lock
point or after six (6) months after FDA approval,
2. Review shall follow SOP of the Pharmacovigilance, and
3. RMP shall be reviewed in instances the identified risks occur which needed
additional risk management.

Annex: The Standard Operating Procedures of Pharmacovigilance

EFFECTIVITY:

This MDH Pharmacy Risk Management Plan (RMP) will take effect after approval
by the Food and Drug Administrations ( FDA ).

MR. WILLIAM LOWELL C. BRAGAT


Hospital Administrator